sme office annual report 2018 - ema.europa.eu€¦ · sme office annual report 2018 the sme office...
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SME office Annual report 2018The SME Office was set up within the European Medicines Agency to address the particular needs of smaller companies
SMEs in numbers
25%40% 35%
10% SMEs incorporated over the last three years: 42% newly created entities; 58% new subsidiaries.
10% Academic spin-offs
Support to SMEs
The Office has dedicated personnel who can help SMEs by:
• Responding to regulatory, procedural and administrativeenquiries
• Setting up briefing meetings to discuss their regulatory strategy
SMEs receive help on how to navigate the array ofservices available at EMA, support in identifying the mostrelevant guidance, and advice on regulatory strategy for aproduct development or authorisation.
175 Direct assistance by phone, email or teleconference 19 Briefing meetings
Regulatory assistance
• Highest figure of EMA registered SMEs since the launch ofthe SME Regulation
• Continued high levels of regulatory support provided toSMEs
• Uptake of scientific advice remains high, in particularprotocol assistance, parallel consultations with regulatorsand health technology assessment bodies, andqualifications of novel methodologies
• Two thirds of SMEs amongst sponsors receiving PRIMEeligibility recommendations
• Highest number of positive opinions for human medicinesand steady success rate
• Attendance at SME info day at record level
• Dedicated support to human and veterinary SMEs forBrexit preparedness
Highlights of 2018
1922
SMEs registered with EMA at the end of 2018
78%
4%
4%
14%
Human medicines
Veterinary medicines
Human and veterinary medicines
Service providers, includingregulatory consultancies
Orphan medicines
23%
Advanced therapies (gene and cell therapy, tissue engineered medicines)
7%
Paediatric medicines
11%
Generic medicines
22%
Out of 1922 SMEs registered, the product pipelines comprise:
Medium-sized (Headcount <250; annual turnover ≤€50 mil or balance sheet total ≤€43 mil)
Micro-sized (Headcount <10; annual turnover or balance sheet total ≤€2 mil)
Small-sized (Headcount <50; annual turnover or balance sheet total ≤€10 mil)
Pre-authorisation (human medicines)
Pre-authorisation (veterinary medicines)
SME Office
SME office Contact the SME Office at EMA E-mail: [email protected]: +31(0)88 781 8787
Research and development support
634 requests for scientific advice and protocol assistance
198, 31% from SMEs
76, 45% from SMEs
168 requests for protocol assistance
8, 30% from SMEs
27 requests for parallel consultations with HTA
5, 56% from SMEs
9 requests for qualification of novel methodologies
8, 32% from SMEs
25 requests for scientific advice for veterinary medicines
Success rate 57%; Average time to opinion 207 days.
Marketing authorisation applications
Human medicines
15
5 513
Veterinary medicines
2
2 3
Initial submissionsApplications with a positive opinion from CHMP/CVMPApplications with a negative opinion from CHMP/CVMPWithdrawn applications
Advanced therapies
8 recommendations for advanced therapy classification1 advanced therapy certification
PRIME
9 out of 14 PRIME eligibilityrecommendations from SMEs
Innovation Task Force (ITF)
9 briefing meetings with the ITF(8 human medicines/1 veterinary medicine)
• Ongoing implementation of EMA's action plans for SMEs,advanced therapies and academia
• Quarterly newsletters highlighting news, documents andactivities in the EU regulatory environment
• Support to Brexit preparedness (information sessions,mailings and assistance to SMEs)
• Info day for micro-, small- and medium-sizedenterprises: regulatory toolbox for medicines andcombined devices developers (125 attendees on-siteand 235 via webcast)
• 3 webinars on IRIS platform (new secure online portalfor sponsors to submit applications for orphanmedicinal product designation and to managepost-designation activities) (159 attendees)
TrainingCommunications and engagement
What is PRIME?